Syntheon LAA Exclusion System, Syntheon LAA Selection Guide

Left Atrial Appendage Clip, Implantable


The following data is part of a premarket notification filed by Syntheon with the FDA for Syntheon Laa Exclusion System, Syntheon Laa Selection Guide.

Pre-market Notification Details

Device IDK220305
510k NumberK220305
Device Name:Syntheon LAA Exclusion System, Syntheon LAA Selection Guide
ClassificationLeft Atrial Appendage Clip, Implantable
Applicant Syntheon 13755 SW 119 Avenue Miami,  FL  33186
ContactSean McBryer
CorrespondentElena Jugo
Caraballo Consulting, LLC 11037 Bitternut Hickory Lane Boynton Beach,  FL  33437
Product CodePZX  
CFR Regulation Number878.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-02-02
Decision Date2022-10-28

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